FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SHEATHLESS ACCESSORY KIT, MODELS XRIK24, XRIK28, XRIK32, XRIK36, XRIK40 AND XRIKRT
K Number: K022620
·
Decision Oct 11, 2002
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
2
Applicant Total
16
Review Days
65
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Basic Information
- Device Name
- SHEATHLESS ACCESSORY KIT, MODELS XRIK24, XRIK28, XRIK32, XRIK36, XRIK40 AND XRIKRT
- K Number
- K022620
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5540
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Spire Biomedical, Inc.
- Date Received
- August 7, 2002
- Decision Date
- October 11, 2002
- Product Code
- FKA
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FKA | Dilator, Vessel | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FKA), ordered by most recent decision date.
VAS-CATH DUALATOR(TM) VESSEL DILATOR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
VESSEL DILATORS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Spire Biomedical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K073092 | DECATHLON TWIN LUMEN HEMODIALYSIS CATHETER WITH SEPARATED TIPS, MODELS DE19SH24, DE23SH28, DE27SH32, DE31SH36, DE35SH40, | Jan 29, 2008 | Substantially Equivalent |
| K073093 | DECATHLON GOLD TWIN LUMEN HEMODIALYSIS CATHETER WITH SEPARATED TIPS, MODELS DEC19SH24, DEC23SH28, DEC23SH32, DEC31SH36, | Jan 22, 2008 | Substantially Equivalent |
| K063441 | 15.5FR ALTA GOLD, COATED HEMODIALYSIS CATHETER, MODEL ALC19SH24, ALC23SH28, ALC27SH32, ALC31SH36, ALC35SH40, ALC50SH55 | Feb 12, 2007 | Substantially Equivalent |
| K063431 | 15.5 FR DECATHLON GOLD, FUNNEL TIPS, COATED HEMODIALYSIS CATHETER, DFC19SH24, DFC23SH28, DFC27SH32, DFC31SH36, DFC35SH40 | Jan 29, 2007 | Substantially Equivalent |
| K062435 | REPAIR KIT FOR XPRESSO, DECATHLON, AND ALTA LR CATHETERS | Dec 5, 2006 | Substantially Equivalent |
| K060288 | RETRO SILVER AND XPRESSO SILVER CHRONIC HEMODIALYSIS CATHETERS | Sep 1, 2006 | Unknown |
| K060155 | 15.5FR DECATHLON COATED TWIN LUMEN CHRONIC HEMODIALYSIS CATHETER WITH SEPARATED TIPS | May 9, 2006 | Substantially Equivalent |
| K042858 | 55CM 15.5FR DECATHLON TWIN LUMEN HEMODIALYSIS CATHETER W/SEPARATED TIPS | Dec 3, 2004 | Substantially Equivalent |
| K041559 | 55CM POURCHEZ RETRO SAFE TRAC TWIN LUMEN HEMODIALYSIS CATHETER MODEL #RS50SH55,RS50NH55,RE50SH55 & RE50NH55 | Jul 30, 2004 | Unknown |
| K040509 | ALTA LR FIXED TIP CHRONIC HEMODIALYSIS CATHETER, MODELS AL19NH24, AL23NH28, AL27NH32, AL31NH36, AL35NH40 | Apr 19, 2004 | Substantially Equivalent |